Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

December 29, 2003

U.S. Suspends Military Anthrax Vaccination Program

Global Security Newswire

The U.S. Defense Department last week announced that it would temporarily suspend its anthrax vaccination program, according to the New York Times (see GSN, Dec. 3).

The Pentagon’s decision followed a recent U.S. federal court ruling that military personnel cannot be forced to take the vaccine, the Times reported. Last Monday, Judge Emmett Sullivan of the U.S. District Court for the District of Columbia issued a preliminary injunction preventing the Pentagon from “inoculating service members without their consent” and ruled that the vaccine used by the Pentagon was “an investigational drug” being used for an unapproved purpose. Sullivan agreed with arguments that the vaccine had only been licensed to prevent the skin form of anthrax, not inhalational anthrax, the Times reported (Thom Shanker, New York Times, Dec. 24).

According to Assistant Defense Secretary William Winkenwerder, the judge’s ruling came in response to a lawsuit filed in March by six anonymous service members. During a Dec. 23 Pentagon press briefing, Winkenwerder defended the anthrax vaccine.

“The anthrax vaccine is safe and effective, and it’s been licensed by the FDA since 1970. The Department of Defense has always complied with, and will continue to comply with all FDA requirements in its use of the anthrax vaccine,” he said.

Winkenwerder cited a March 2002 Institute of Medicine report, which said that the current anthrax vaccine is effective for preventing anthrax, including inhalational anthrax, in humans. He also countered Sullivan’s claim that the current vaccine had not been approved for use to prevent inhalational anthrax, saying, “it’s a licensed product against all forms of anthrax.”

“In summary, this court ruling is not supported by medical science or by medical facts. It challenges the conclusions of America’s best medical experts,” Winkenwerder said (U.S. Defense Department release, Dec. 23).

On Wednesday, the U.S. Justice Department filed a motion requesting that Sullivan withdraw his preliminary injunction against the Pentagon’s anthrax vaccination program, or to agree to limit the injunction to only the six plaintiffs in the March lawsuit, according to the New York Times.

The motion asks for a clarification as to whether the injunction only applies to the six plaintiffs. If not, then it asks that Sullivan reconsider the injunction because the suit was not filed on behalf of all U.S. military personnel, the Times reported.

“Plaintiffs never pursued this case as a class action,” the motion says. “An award of preliminary injunctive relief to anyone other than the six Doe plaintiffs before the court would be wholly without justification,” it says.

Mark Zaid, one of the plaintiffs’ lawyers who provided a copy of the motion to the Times, said that while the motion was “understandable from the legal standpoint,” it was “completely absurd from a policy standpoint.”

“The vaccine as being used is experimental in nature and therefore unlawful unless informed consent is given,” Zaid said. “So to argue that this decision should only apply to those six individuals does a real injustice,” he said (Thom Shanker, New York Times, Dec. 27).

December 23, 2003

Judge rules Pentagon can not force military to take vaccine.

The Pentagon must stop forcing members of the military to take the anthrax vaccine against their will, unless President Bush signs a special order, a judge ruled Monday.

Department of Defense officials argued that refusing the shots puts other service members at risk.

Six plaintiffs working for the military in sworn and civilian positions filed a class action suit in May after being ordered to take the vaccine. Three obeyed the order and three did not.

The news of Monday's court ruling came to Moses Lacy of Lynwood as his family prepared to face its first Christmas since his daughter Rachael's death this spring. A coroner ruled the anthrax shots were contributing factors in the U.S. Army Reservist's death, and the Pentagon announced last month that the vaccines may have caused her death.

"That is the best Christmas present a person can have," Moses Lacy said. "I'm touched."

Rachael Lacy, 22, died in April after receiving the vaccination, along with a smallpox inoculation.

She made no attempt to refuse the vaccines, but others who have faced the consequences. Military records show some half a million service members have received the vaccine since they became mandatory in 1998.

Some servicemen and women have faced disciplinary action, even courts-marshal, for refusing the shots. Because the program is administered by military commanders -- not doctors -- refusing the shots was considered refusing an order.

Maj. Thomas "Buzz" Rempfer, of the Connecticut Air National Guard, refused to take the vaccine in 1998 and was subsequently grounded. He has been a strong voice in the fight against requiring the inoculations.

Rempfer -- speaking on his personal opinions and not on behalf of the military -- praised Monday's decision.

"The legislation that will naturally follow from this federal court decision will hopefully be enacted in memory of U.S. Army Reserve Specialist Rachael Lacy," Rempfer said. "Her ultimate sacrifice will set a precedent where our (Department of Defense) will never again be allowed to knowingly and illegally experiment on our soldiers."

Monday's decision is a preliminary injunction requested by the military personnel as part of its suit.

The risk of anthrax exposures to service members was feared to have been from anthrax weapons the military believed were being produced by Iraq and other nations.

Critics have argued for years that the vaccines were never given proper Food and Drug Administration approval for use in fighting inhalation anthrax. The Pentagon contends the vaccine is safe and effective for all forms of anthrax.

U.S. District Court Judge Emmet G. Sullivan said in his ruling Monday that the rate of adverse reaction to the vaccine was recently revised from 0.2 percent to between 5 percent and 35 percent. Six deaths have been attributed to the shots, he said.

Sullivan said the anthrax vaccinations fall under a 1998 law prohibiting the use of certain experimental drugs unless people being given the drug consent or the president waives the consent requirement.

"The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy," Sullivan said in his ruling. "Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs with experimental drugs."

The Pentagon had no immediate comment.

Moses Lacy said Monday that the judge's ruling echoed the sentiments he has had about the drug since Rachael's death.

"That's what I've been saying all along, that they shouldn't be giving it without informed consent," he said.

Rachael Lacy was studying to be a nurse when she was called to active duty in February. The South Suburban College student worked at a Lansing pizzeria and was a member of the 452 Combat Surgical Hospital unit out of Milwaukee, where she served as a combat medic.

Her unit arrived at Fort McCoy, Wis., on Feb. 27 to prepare for deployment to the Middle East.

She received the smallpox and anthrax vaccines along with the other soldiers in her unit within the week. Rachael began feeling ill March 17, and she went to a local emergency hospital in Sparta, Wis., about seven miles from Fort McCoy.

The doctors there began giving Rachael antibiotics, thinking she had pneumonia. She was then referred and admitted to a hospital in LaCrosse, Wis. When Rachael's condition did not improve, she was sent to the Mayo Clinic in Rochester, Minn., on April 2.

She died there three days later.

The official cause of death noted on the death certificate is diffuse alveolar damage, meaning widespread damage to the sacks of the lungs.

Contributing conditions listed on the death certificate included, "recent smallpox and anthrax vaccination."

Moses Lacy said he found "a great deal of comfort" in the judge's ruling Monday and felt his daughter's death contributed to the outcome.

"If it had not been for my daughter Rachael's passing, I think it would have continued," he said. "Nobody would have taken a good look at it.

"Certainly there have been other young men and women who have died and become ill (as a result of the vaccines), but I think my daughter's death was the spearhead that brought this to where it is right now. Although it will not bring her back, I think it should be in her honor."

The Associated Press contributed to this report.

Lauri Harvey can be reached at lharvey@nwitimes.com or (219) 933-4169.

December 11, 2003

Mandatory anthrax shots stir health fears, sap morale

USA Today

Ohio National Guardsman Kurt Hickman expected to head to Iraq or Afghanistan after getting a call-up notice days before Thanksgiving. Instead, his more likely destination is a jail cell. Hickman, 20, faces trial Saturday for refusing a mandatory anthrax vaccine he fears isn't safe. More than 500 other soldiers already have received punishments ranging from demotions to court-martials for refusing required anthrax shots.

The Pentagon says vaccines are essential to protect soldiers' health — particularly from anthrax in Iraq, which developed biological agents. But that doesn't trump the Defense Department's equal obligation to investigate and weigh potential problems.

Instead, it clings to its policy of mandatory vaccinations, even as other countries are moving toward voluntary programs with successful results. The dug-in U.S. position forces concerned soldiers to choose between possibly endangering their health and ending their military service at a time when troop strength already is stretched.

Concerns fall into two categories:

Safety. According to a 2002 survey by the General Accounting Office (GAO), the investigative arm of Congress, 84% of the Air Force Reserve and National Guard troops who received anthrax vaccines since they became mandatory in 1998 had reactions. They included difficulty breathing, muscle aches, headaches and dizziness.

The Pentagon acknowledges that the death of reservist Rachel Lacy, 22, last April may have resulted from an anthrax vaccine. Veterans' groups; the National Vaccine Information Center, a public awareness group; and some members of Congress are calling for better research to determine whether more than 10 other deaths and hundreds of illnesses, from pneumonia to blood clots, may be linked to the vaccines.

Morale. The GAO said concern about mandatory anthrax shots was the main reason cited by two thirds of pilots and crew who left Air Force guard and reserve units from 1998 to 2000. After then vaccines were curtailed for two years because of shortages. Yet the Pentagon increasingly relies on these forces to relieve regular troops. Recruiters fear long tours of duty may drive many reservists away; mandatory shots are an added worry. The Army Reserve already missed a retention goal by 6.7% this year.

The Pentagon insists its vaccinations are safe. And for most people, they are.

But they aren't risk-free. Last year, the Food and Drug Administration warned that 5% to 35% of those who get shots could experience any of 40 side effects. About 6% of reactions can cause death, hospitalization or permanent disability.

Those risks, combined with the U.S. military's failure to find any biological weapons in Iraq so far, make a strong argument for a moratorium on mandatory vaccines — at least while two safer anthrax vaccines are being developed.

Britain, with the most troops in Iraq after the U.S., made the anthrax vaccine voluntary this year. Since then, more than half of its soldiers have refused the shots. Australia, which also has troops in Iraq, has a voluntary anthrax vaccination policy as well.

By giving soldiers a choice about receiving vaccines as more studies on the health hazards are conducted, the Pentagon could ensure that soldiers like Hickman serve time where they're needed most.

December 8, 2003

Demolished: The Myth That Allows Drugs Giants to Sell More

For years, the drugs industry has grown fat on a myth - the false belief that all drugs will work on just about everybody.

That has essentially been the rationale for a culture that has encouraged doctors to prescribe first and ask questions later - at a cost to the NHS of £7.2bn a year in medicines.

Yet it has been an open secret within the drugs industry that most drugs do not work for most patients, a secret that has now been publicly aired for the first time by Allen Roses, the head of genetics at GlaxoSmithKline, Britain's biggest drugs company.

Dr Roses, an academic with a distinguished record in medical genetics, is used to speaking his mind, especially on the benefits of a revolutionary new approach to drug development called pharmacogenomics.

That is the science of applying the results of the human genome project to drug development. In essence, it means testing the DNA of patients in order to identify those for whom a particular drug will work - the "responders".

That would enable doctors to eliminate the "non responders" who, as a result, will at least not be given a drug that at best could be useless and at worst dangerous in terms of harmful side-effects.

In the past, drug companies have developed drugs aimed at the widest possible population. That was the most profitable strategy but one that ignored a basic fact in biology - people are different.

To emphasize the point, Dr Roses likes to quote Sir William Osler, a Canadian physician who in 1892 remarked: "If it were not for the great variability among individuals, medicine might as well be a science and not an art."

Bringing a new drug to market is an expensive business costing tens of millions of pounds. It takes place in a culture of maximum possible sales for maximum possible profit - a culture that does not like to broadcast the fact that most drugs don't work for most people.

Drug testing in patients involves three phases of increasingly complex clinical trials that must be successfully completed before the drug is approved by regulatory authorities such as the mighty US Food and Drug Administration.

But even when a drug has been approved in terms of safety and "efficacy" - whether it does what the label says it should do - few people realize just how poorly they perform in real life.

Dr Roses cited a study published three years ago by Brian Spear, a senior scientist at Abbott Laboratories, a medical diagnostics company in Chicago, on the efficacy rates of a range of different drugs.

It found that drugs vary enormously in terms of how well they work, with efficacy rates varying from as low as 25 per cent for cancer drugs to 80 per cent for painkillers.

For many drugs, however, the efficacy rates hover around 50 per cent or lower, meaning that, for most people, these drugs just don't work. As Dr Roses puts it: "The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people."

Dr Roses is one of the pioneers in a field of genetics that promises to help to identify those people who could benefit from a drug. It is called single nucleotide polymorphisms (SNPs) and it is a way of distinguishing the smallest possible genetic differences between individuals.

The use of SNPs has already led to the discovery, for instance, of a test to detect the 5 per cent of the population who inherit a predisposition to a potentially fatal side effect of an anti-HIV drug called abacavir.

Now it is possible to test HIV patients before the drug is given to them in order to weed out those patients who will suffer a severe adverse reaction - a violent rash on the body.

Scientists believe that SNPs can be used to test people not just for their vulnerability to a drug's side-effects, but also to whether it will work or not.

John Bell, the regius professor medicine at Oxford University, said that for pharmacogenomics to catch on, doctors will have to learn new ways of dealing with patients.

"One of the biggest obstacles is culture. We've all been taught to take the dose for a drug straight out of the British National Formulae and then if that doesn't work to add another drug to the prescription, and so on," Professor Bell said.

"So we can end up with lots of patients on four or more drugs where only one would do. This is a big cultural issue to overcome," he said.

Apart from the ethics of prescribing useless drugs to people who could be poisoned by them, there is also the question of costs to the NHS, which has seen a record 50 per cent increase in its drugs bill over the past three years.

As Bill Clarke, the executive vice president of research at Amersham, a British diagnostics company, said: "It's just not right to spend that amount of money on drugs that don't work." For the sake of a relatively cheap genetics test that can be carried out on the wider population of patients, it would be possible to target drugs more effectively and more safely, Dr Clarke said.

It could also lead to a revolution in the way drugs are tested, he said. If "responders" to a new drug can be identified easily, it will be possible to simplify the expensive phase 3 clinical trials which can involve thousand of people being followed over many years.

Dr Roses agreed: "You can pick out people who respond a lot to the drug, can you pick out people who do not respond at all to the drug and can you pick out people who are sort of in the middle.

"By eliminating the people that we predict will be non-responders we'll be able to do smaller, faster and cheaper drug trials."

That could be the incentive that will lead to a change in the "one-drug-fits-all" culture of the drug industry, he said.

"I can't speak for other companies but I can tell you absolutely for sure that there is a change in the culture of GSK," Dr Roses said. And the advent of pharmacogenomics will not necessarily mean a fall in sales.

"If you can determine who is going to have a response [to a drug] and who is not going to have a response, you can take your next molecule and aim it specifically at the people who haven't had a response with the first one so that you can create a set of drugs that cover the population, and then you are back to selling to everybody," he said.

Trial approach

PHASE I: These first studies evaluate how a new drug or therapy should be given (by mouth, injection into the blood or injection into the muscle), how often, and what dose is safe. A phase I trial usually enrolls a small number of patients, sometimes as few as a dozen.

PHASE II: A phase II trial usually focuses on one type of illness, continuing to test the safety of treatment and beginning to evaluate how well it works. This is the essential intermediate step that will determine whether the drug will go into bigger and more costly phase III trials.

PHASE III: These studies test a new drug, a new combination of drugs or a new therapy in comparison to the current standard treatment. A participant will usually be assigned to the standard group or the new group at random (called randomization). Often it involves "double blind" trials, where neither the patient nor doctor knows who is being given the new drug. Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.

Injections Said to Hamper Bioterror Fight

By BILL BERGSTROM, AP

PHILADELPHIA (AP) - Coming up with medicines that can be given in a nasal spray or by slapping on a patch rather than injections would be a big help in developing and stockpiling vaccines against major bioterrorism threats, an official involved in the government's Project Bioshield said Sunday. Trying to prepare and administer injections to the entire populations of even just major urban areas would be unwieldy and impractical, Dr. Philip K. Russell said in a talk wrapping up a meeting of the American Society of Tropical Medicine and Hygiene in Philadelphia.

"That could crush the public health structure, if you needed a multi-dose vaccine," said Russell, an official in Health and Human Services Department's Office of Public Health and Preparedness.

As director of the department's Office of Research and Development, Russell is a senior adviser on vaccine development and production, the goal of the proposed $5.6 billion federal Bioshield Act, now pending in the Senate. Russell said officials hope for passage of the act early next year.

Meanwhile, the program has already taken its first steps, he said. The National Institutes of Health has so far awarded two contracts for development of a second-generation anthrax vaccine, to VaxGen Inc. in San Francisco and to Avecia in England.

Biotechnology companies have been seeking a more effective anthrax vaccine since the 2001 anthrax mail attacks that killed five people, because the only vaccine now approved requires six shots over 18 months, plus an annual booster, and can cause side effects.

In addition to trying to reduce the number of shots, scientists will discuss other ways of administering vaccines at a conference his department is coordinating Dec. 18 and 19 in Rockville, Md., including jet injectors, transdermal patches and oral and nasal sprays.

Health officials also want to be sure vaccines being developed for Project Bioshield won't deteriorate in storage, Russell said.

"I don't want to put a lot of stuff in the stockpile that ends up being thrown away in a few years, and has to be replaced at a cost of hundreds of millions of dollars," said Russell, former director of the Army Medical Institute of Infectious Diseases and commander of the Army Medical Research and Development Command.

Arranging trials of new vaccines also will be time consuming, Russell said, adding that it isn't yet known when the first new vaccines might be delivered.